BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2870374 · Received December 12, 2012

    Report

    Report Number
    3006630150-2012-02314
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-8216-50, SERIAL: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM; EXPLANTED IPG AND LEAD WILL NOT BE RETURNED TO BSN AS THEY WERE DISCARDED BY MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED DISCHARGE, SWELLING, AND DISCOLORATION OF THE IMPLANT SITE. ORAL ANTIBIOTICS WERE ADMINISTERED AND THE PATIENT UNDERWENT AN EXPLANT OF THE ENTIRE SCS SYSTEM. THE PATIENT IS REPORTEDLY WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention